2016, Communication and Method Validation - Pharmacy Technician Pulse

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2016

Communication

Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

BioProcess International 14 (2016): 38–43. Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies.

Documentation

Documentation FDA Communication Packaging

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

Although ANVISA has been an ICH member since 2016, the implementation plan of ICH guidelines is still ongoing. Published 29 February 2016. You may unsubscribe from these ISPE communications at any time. Key to the success of this process is the commitment of the ICH regulators to implement the final guidelines. Position paper.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

CMC Requirements for New Drug Registration in Latin America

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